Ignite Creation Date:
2024-05-06 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03555877
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2018-02-16
Brief Title:
Anti-hormonal Therapie With Ribociclib in HR-positive HER2- Negative Metastatic Breast Cancer
Sponsor:
German Breast Group
Organization:
German Breast Group
Study Overview
Official Title:
Anti-hormonal Maintenance Treatment With the CDK46 Inhibitor Ribociclib After 1st Line Chemotherapy in Hormone Receptor Positive HER2 Negative Metastatic Breast Cancer A Phase II Trial
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMICA
Brief Summary:
This is a multicenter prospective randomized open-label controlled phase II study to test the addition of the CDK46 inhibitor ribociclib to anti-hormonal treatment as maintenance therapy in patients with disease control at least stable disease after 1st line chemotherapy
Detailed Description:
Although 1st line chemotherapy is effective in women with HR-positive HER2-negative breast cancer PFS is usually around 6-8 months and 2nd or 3rd line treatments are by far less effective Well tolerated maintenance treatments with the potential to prolong PFS and even OS are urgently needed This study evaluates the impact of the addition of a CDK46 inhibitor to an anti-hormonal maintenance treatment of physicians choice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None